Osteomed LP: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Osteomed LP” (first 2003, latest 2015), across 12 product codes in 3 review panels. Median 510(k) review time under this name: 110 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 80 |
| 2013 | 2 | 98 |
| 2014 | 1 | 84 |
| 2015 | 1 | 132 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 7 | 7 |
| MQN | External Mandibular Fixator And/Or Distractor | 5 | 5 |
| HWC | Screw, Fixation, Bone | 3 | 3 |
| JEY | Plate, Bone | 3 | 3 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 3 | 3 |
| DZE | Implant, Endosseous, Root-Form | 2 | 2 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 1 | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| MRW | System, Facet Screw Spinal Device | 1 | 1 |
Plus 2 more product codes.
Review panels
- Orthopedic (16)
- Dental (11)
- Neurology (2)
Most recent Osteomed LP 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143338 | Argulated Locking Plates | JEY | 2015-04-01 | 132 |
| K133691 | EXTRIMILOCK ANKLE PLATING SYSTEM | HRS | 2014-02-24 | 84 |
| K131445 | OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM | HRS | 2013-06-18 | 29 |
| K123885 | OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR | PBJ | 2013-06-03 | 167 |
| K123207 | PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM | MAX | 2012-11-29 | 48 |
| K120015 | OSTEOMED WRIST PLATING SYSTEM | HRS | 2012-04-24 | 112 |
| K111419 | OSTEOMED HAND FUSION SYSTEM | HRS | 2011-10-07 | 140 |
| K111176 | OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM | GWO | 2011-08-15 | 110 |
| K102438 | PRIMALOK FACET FIXATION SYSTEM | MRW | 2010-09-30 | 35 |
| K100354 | PRIMAL OK INTERSPINOUS FUSION SYSTEM | KWP | 2010-08-17 | 186 |
19 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2011-06-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Osteomed Corp. (39 510(k)s)
- Osteomed, LLC (5 510(k)s)
- Osteomed Implantes, Ltda (3 510(k)s)
- Osteomed Indústria E Comércio DE Implantes Ltda (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Osteomed LP?
FDA lists 29 510(k) clearances under the applicant name “Osteomed LP” (first 2003, latest 2015), across 12 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Osteomed LP?
The median time from FDA receipt to decision across 510(k)s cleared under the name Osteomed LP is 110 days.
Which FDA product codes appear under Osteomed LP?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 7); MQN (External Mandibular Fixator And/Or Distractor, 5); HWC (Screw, Fixation, Bone, 3).
Next steps
- See all 29 Osteomed LP clearances with predicates and recalls
- Run predicate analysis for product code HRS, Osteomed LP's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.